NCT04219943

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of conservative treatment in treatment of patients over 75 years with impacted femoral neck fracture.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

6.8 years

First QC Date

January 5, 2020

Last Update Submit

January 5, 2020

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (3)

  • visual analog scale

    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent

    36 months

  • Harris hip score

    The score has a maximum of 100 points (no disability), covering pain (0-44 points), function (0-47 points), and range of motion and absence of deformity (0-9 points).

    36 months

  • Eq-5d index scores

    To rate current state of health on five dimensions (mobility, personal hygiene, usual activities, pain/discomfort, and anxiety/depression) with three possible responses for each item (no problem, some problem, unable/large problem). Integral formula: V=1-Constant-Mobility-Self-care-Usual activity-Pain/discomfort-Anxiety/depression-N3.

    36 months

Study Arms (1)

Conservative Treatment for Impacted Femoral Neck Fracture

EXPERIMENTAL

Conservative Treatment for Impacted Femoral Neck Fracture

Procedure: Surgical Treatment for Impacted Femoral Neck Fracture

Interventions

Surgical Treatment for Impacted Femoral Neck FracturePROCEDURE

Surgical Treatment for Impacted Femoral Neck Fracture

Conservative Treatment for Impacted Femoral Neck Fracture

Eligibility Criteria

Age75 Years - 97 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Patients \<75 years old, pathological fracture, nonimpacted or displaced fracture, unable to walk previously, avascular necrosis of femoral head, previous symptomatic hip pathology (such as arthritis), infection, a history of fracture in the studied hip, deformity of lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wei P, Xu Y, Gu Y, Geng D, Yao Q, Wang L. Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture in Patients 75 Years and Older. J Am Geriatr Soc. 2020 Oct;68(10):2214-2221. doi: 10.1111/jgs.16535. Epub 2020 May 15.

    PMID: 32413174DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

January 1, 2010

Primary Completion

October 31, 2016

Study Completion

October 31, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01